We are seeking a QA Operations Specialist to support Quality Assurance activities within a biopharmaceutical manufacturing environment at the LSCC site in Devens, MA. This role provides on-the-floor QA support to manufacturing operations, ensuring compliance with company policies, procedures, and global cGMP requirements.
The QA Operations Specialist performs real-time batch record review, reviews manufacturing shop floor documentation, and supports quality decision-making in a regulated GMP environment. The role requires independent judgment, strong documentation skills, and the ability to partner effectively with manufacturing and cross-functional teams.
This is an intermediate-level role requiring 4–7 years of relevant experience.
Work Schedule
This position follows a rotating two-week schedule with 12.5-hour shifts (5:00 AM – 5:30 PM):
Week 1
• Work: Tuesday, Wednesday
• Off: Thursday, Friday
• Work: Saturday, Sunday, Monday
Week 2
• Off: Tuesday, Wednesday
• Work: Thursday, Friday
• Off: Saturday, Sunday, Monday
The two-week rotation repeats continuously.
Holidays are worked as business needs require.
Key Responsibilities:
- Provide on-the-floor QA support to manufacturing operations;
- Ensure compliance with approved procedures and batch records;
- Perform real-time review of manufacturing batch records;
- Review and approve shop-floor manufacturing documentation;
- Identify, assess, and escalate quality issues as appropriate;
- Support deviation investigations, change controls, and CAPA activities;
- Apply Quality Risk Management principles in daily decision-making;
- Partner cross-functionally to support continuous improvement initiatives;
- Develop and revise GMP procedures as required.
Requirements
Must Haves:
- Required manufacturing shop floor documentation experience.
- Strong authorship skills with the ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management principles.
Required Qualifications:
- Associate’s or Bachelor’s degree in a relevant discipline.
- Minimum 4 years of relevant Quality Assurance experience in an FDA-regulated cGMP environment.
- Strong knowledge of US and global cGMP requirements.
- Experience supporting GMP manufacturing and/or warehousing operations.
- Working knowledge of quality processes including deviations, investigations, change control, material disposition, product complaints, and CAPA management.
- Ability to work independently with moderate direction on complex tasks.
- Confidence in making decisions for non-routine quality issues.
- Strong written and verbal communication skills.
- Strong organizational skills with the ability to multitask in a fast-paced manufacturing environment.
Benefits
Competitive hourly rate: $50 – $57.8/hr (W-2 only, no C2C)
12-month contract with possible extension
Health insurance, holiday pay, 401(k) program, and other benefits
Employee referral bonus program
Skills Required
- Required manufacturing shop floor documentation experience
- Strong authorship skills to review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management
- Associate's or Bachelor's degree in a relevant discipline
- Minimum 4 years of Quality Assurance experience in an FDA-regulated cGMP environment
- Strong knowledge of US and global cGMP requirements
- Experience supporting GMP manufacturing and/or warehousing operations
- Working knowledge of quality processes: deviations, investigations, change control, material disposition, product complaints, CAPA management
- Ability to work independently with moderate direction on complex tasks
- Confidence in making decisions for non-routine quality issues
- Strong written and verbal communication skills
- Strong organizational skills and ability to multitask in a fast-paced manufacturing environment
- Ability to follow a rotating two-week schedule with 12.5-hour shifts, including holiday work as required
What We Do
SOKOL GxP Services is a specialized firm providing Commissioning, Qualification, and Validation (CQV) services to the pharmaceutical, biotech, and cell therapy industries. They focus on quality-driven, agile, and lean operational support to ensure regulatory compliance and inspection readiness. Additionally, they operate the SOKOL GxP Academy, which provides training in GMP fundamentals and professional development to support the life sciences workforce.
